Philbin Morgan M, McCrimmon Tara, Shaffer Victoria A, Kerrigan Deanna, Pereyra Margaret, Cohen Mardge H, Sosanya Oluwakemi, Sheth Anandi N, Adimora Adaora A, Topper Elizabeth F, Rana Aadia, Tamraz Bani, Goparaju Lakshmi, Wilson Tracey E, Alcaide Maria
Department of Sociomedical Sciences, Columbia University Mailman School of Public Health, New York, NY, United States.
Department of Health Sciences, University of Missouri, Columbia, MO, United States.
JMIR Res Protoc. 2022 Sep 13;11(9):e35646. doi: 10.2196/35646.
Many women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the US Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women's adherence and long-term HIV outcomes.
This study will develop and pilot test a web-based patient decision aid called i.ART+support (i.ARTs). This decision aid aims to support shared decision making between WWH and their providers, and help women choose between oral and LAI HIV treatment.
The study will occur in 3 phases. In phase 1, we will utilize a mixed methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In phase 3, i.ARTs will be tested in a randomized controlled trial with 180 women in Miami, Florida, and assessed for feasibility, usability, and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART pharmacy refills, and clinic attendance.
This study was funded in March 2021. Columbia University's IRB approved the study protocols (approval number IRB-AAAT5314). Protocols for phase 1 interviews have been developed and interviews with service providers started in September 2021. We will apply for Clinicaltrials.gov registration prior to phase 3, which is when our first participant will be enrolled in the randomized controlled trial. This is anticipated to occur in April 2023.
This study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed methods design, and implementation in a real-world clinical setting.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35646.
许多感染艾滋病毒的女性（WWH）由于在获得和保留艾滋病毒治疗方面存在多层次障碍，对抗逆转录病毒疗法（ART）口服药物的依从性欠佳。一种长效注射用抗逆转录病毒疗法（LAI）于2021年1月获美国食品药品监督管理局批准，它无需每日服药，有可能克服诸多此类障碍。然而，它可能并非对所有感染艾滋病毒的女性都最为适用。开发有助于患者与医疗服务提供者就口服与长效注射用抗逆转录病毒疗法模式进行共同决策的工具，对于提高女性的依从性和改善长期艾滋病毒治疗效果至关重要。
本研究将开发并试点测试一款名为i.ART+support（i.ARTs）的基于网络的患者决策辅助工具。该决策辅助工具旨在支持感染艾滋病毒的女性及其医疗服务提供者之间的共同决策，并帮助女性在口服和长效注射用艾滋病毒治疗之间做出选择。
该研究将分三个阶段进行。在第一阶段，我们将采用混合方法从感染艾滋病毒的女性以及医疗和社会服务提供者那里收集数据，以为i.ARTs的内容提供信息。在第二阶段，我们将与感染艾滋病毒的女性和医疗服务提供者进行焦点小组讨论，以完善i.ARTs的内容并开发基于网络的决策辅助工具。在第三阶段，i.ARTs将在佛罗里达州迈阿密对180名女性进行的随机对照试验中进行测试，并评估其可行性、可用性和可接受性，同时评估接受i.ARTs与病毒抑制、抗逆转录病毒疗法药房配药以及门诊就诊之间的关联。
本研究于2021年3月获得资助。哥伦比亚大学的机构审查委员会批准了研究方案（批准号IRB - AAAT5314）。第一阶段访谈的方案已制定完成，对服务提供者的访谈于2021年9月开始。我们将在第三阶段之前申请在Clinicaltrials.gov注册，届时我们的第一名参与者将被纳入随机对照试验。预计这将在2023年4月进行。
本研究首次开发了一种基于网络的患者决策辅助工具，以支持感染艾滋病毒的女性在口服和长效注射用抗逆转录病毒疗法之间做出选择。其优势包括纳入了患者和医疗服务提供者的观点、混合方法设计以及在实际临床环境中的实施。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/35646。
